Ethics
In this section you find answers to ethical issues surrounding medical biobanks and databases. Questions about your privacy, consent, confidentiality, remuneration and compensations are answered here. The answers are a result of a collaboration between the European Genetic Alliances Network (EGAN) and Roche.
The answers given to the questions are inevitably general. They may not all apply in every detail to any particular biobank, so if you are asked to volunteer and you have specific issues you wish to resolve, you should discuss them with the sample collector or other responsible persons before proceeding.
- What permission do biobanks need from me in order to do research?
- Can I say no to the use of my samples in particular types of research?
- Will I be told about my results?
- Who will be able to see information about me held in a biobank?
- Will the police be able to get access?
- Will insurance companies be able to get access?
- Can I leave a biobank after I have joined one?
- Can healthcare companies pay to see public sector biobanks?
- Will being in a biobank give me any direct benefit such as better medicinal care or a financial reward?
- More websites on Ethics and Biobanks
1. What permission do biobanks need from me in order to do research?
If you donate samples to a biobank, you will need to give explicit consent to the use of your samples for a particular purpose before they can be used by the researchers.
Samples cannot be taken or used without your permission, though if you agree to give 'blanket' consent, you may not be told how they are used in the future for further research. The kind of consent you give then limits the research that may be done using your samples.
If you donate samples to a biobank for research, you should have the right to withdraw them at any time!
Please see the "informed consent" section in EuroGenGuide for detailed information
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2. Can I say no to the use of my samples in particular types of research?
This should be discussed when you consent to donating your sample to the biobank.
In theory, yes. However, it is likely to be too complex for most biobanks to offer individuals the choice of opting out of some types of research. Instead you may prefer to choose not to volunteer.
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3. Will I be told about my results?
This should be discussed when you consent to donating your sample to the biobank, but generally participants are not told results of biobank research.
If the study you are involved with is one where the DNA samples are coded or anonymised, then there may be no way for you to find out your results, even if you would like to find out.
Once again, your health professionals must tell you what form the research will take before you agree to donate a sample.
Whether or not the results of research using your DNA samples are fed back to you depends mainly on the particular study being carried out. If feedback is offered to you, it is also up to you to decide whether or not you wish to receive it.
If during the research, the researchers discovered that you have, or will develop, a genetic disorder, this may give you the opportunity to start taking preventative measures and begin treatment at an early stage.
However, some people may prefer not to know about such results, especially if no preventative measure or treatment exists for that particular condition.
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4. Who will be able to see information about me held in a biobank?
If you are going to participate in a biobank, those taking the samples should always tell you who will have access to their information. It is usual that just the organization that takes your sample will know personal details such as your name and address.
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5. Will the police be able to get access?
Firstly, most biobanks are anonymised so there is no way to ever link an identifiable individual to a particular set of data. Secondly, biobanks contain what is known as 'medical confidential information' and so are inaccessible by the authorities except in the most extreme cases where there is a specific public safety concern.
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6. Will insurance companies be able to get access?
If you are considering becoming part of a genetic research study, one question you may have is whether or not insurance companies will be able to access personal genetic information about you.
Whether or not insurance companies are entitled to know personal genetic information, and whether or not you are obliged to tell them varies depending on the way in which you discovered that you have a condition.
Diagnostic testing
If you discovered that you are a carrier of a diseased because you were exhibiting symptoms of illness and were tested for a diagnosis, then you are obliged under UK law to provide this information to insurers.
Predictive testing
If you found this information out because a member of your family had a condition and you got a test to find out whether or not you will as well, then you are similarly obliged to tell your insurer.
Genetic research
The situation is different for information discovered in the course of genetic research. You may be a member of the public who was not undergoing medical treatment but decided independently to participate in a research study. You may have discovered coincidentally through the study that you are a carrier of a disease. In cases like this, you are not obliged to tell your insurers of your condition.
The issue of insurance is one that has already been noted by governments and legislative bodies. The World Health Organisation has recognised that participants in research, who may suffer from a disorder, are in a vulnerable position in relation to insurers, and therefore discourages these participants from granting insurers access to their genetic information.
This is only an issue however in cases where DNA samples have not been anonymised and the donor is still identifiable. Where the samples have been anonymised and there is no danger of identification, there would be no personal information for an insurance company to use.
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7. Can I leave a biobank after I have joined one?
This depends on the biobank and on what you agree when you join.
The right to withdraw consent, and the implications of doing so, should be fully explained when you provide a sample for the biobank.
Whilst an individual has the right to withdraw consent, it may be impossible for biobanks that anonymise samples to be able to identify your particular sample in order to destroy it.
Withdrawal is only possible if the anonymization process has not taken place. Also, if analyses have already been performed on your sample, it is likely to be impossible to erase results from databases or reports that may have already been issued.
However, where samples have not been anonymised, you should have the right to withdraw your samples at any point if you wish.
8. Can healthcare companies pay to see public sector biobanks?
Some biobanks make their samples and/or data available to any interested researchers, whether from the public or commercial sector.
It is also possible that the public sector biobank will charge researchers a fee for having access to their samples and/or data.
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9. Will being in a biobank give me any direct benefit such as better medicinal care or a financial reward?
Donation of a sample to a biobank is almost always voluntary and undertaken for altruistic rather than for monetary motives, namely to help move research along and ultimately make progress in creating better medicines.
Generally, you will be reimbursed for expenses incurred, such as travel costs and/or time off work, but there will not be any further direct benefit for you in terms of treatments. The hope is that new knowledge can be generated through research to reveal samples on disease causes and future treatment options.
However, in order that the DNA donors who enable the research to go ahead are 'reimbursed' for their donation and can benefit from their investment in the research as well, the research organisation can sometimes offer benefits in a range of ways. These are explained fully in the EuroGenGuide section on 'Access and benefit sharing'
10. More websites on Ethics and Biobanks
- The UK Biobank Ethics and Governance Council (EGC) is an independent committee established by the Wellcome Trust and the Medical Research Council.
- An Ethics Guide for International Review Boards (IRBs), researchers and policymakers can be found here.